Optimizing the Evaluation of Awareness in Disorders of Consciousness
CONPHIDENSE
Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedDecember 11, 2015
December 1, 2015
1.9 years
December 8, 2015
December 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols
Depending of the personalized stimulation protocol, the differences of electrophysiological activity can the presence of event-related potentials (N100, mismatch negativity, P300, etc.) or alterations of neural oscillations. The personalized stimulation protocol will be chosen according to the families' feeling of a presence.
standard stimulations: 28 days after recruiting patients
Study Arms (1)
electroencephalography recording
EXPERIMENTALCerebral measurements from high-density electroencephalography after the presentation of personalized stimulations
Interventions
Eligibility Criteria
You may qualify if:
- patients in a vegetative state or a minimally conscious state
- agreement from families
You may not qualify if:
- patients with akinetic mutism or locked-in syndrome
- patients in a coma
- patients with damages in the inner or middle ear
- contraindication to a high-density electroencephalography exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Pazart L, Gabriel D, Cretin E, Aubry R. Neuroimaging for detecting covert awareness in patients with disorders of consciousness: reinforce the place of clinical feeling! Front Hum Neurosci. 2015 Feb 17;9:78. doi: 10.3389/fnhum.2015.00078. eCollection 2015. No abstract available.
PMID: 25741272BACKGROUNDGabriel D, Henriques J, Comte A, Grigoryeva L, Ortega JP, Cretin E, Brunotte G, Haffen E, Moulin T, Aubry R, Pazart L. Substitute or complement? Defining the relative place of EEG and fMRI in the detection of voluntary brain reactions. Neuroscience. 2015 Apr 2;290:435-44. doi: 10.1016/j.neuroscience.2015.01.053. Epub 2015 Jan 30.
PMID: 25644421BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Régis Aubry, MD, PhD
Service douleur - soins palliatifs
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2015
First Posted
December 11, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Last Updated
December 11, 2015
Record last verified: 2015-12